AstraZeneca puts Oxford coronavirus vaccine trails on hold after participant falls illSeptember 10, 2020 0 By FM
Phase 3 trials of the front-runner candidate vaccine have been temporarily halted following a suspected adverse event in a person who received the vaccine in the UK.
Details or the nature of the reported adverse event has not been revealed by the developers.
The New York Times has reported that a volunteer in the UK trial had received a diagnosis of transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often triggered by viral infections, quoting an unnamed source.
The AZD1222 coronavirus vaccine is being developed by Oxford researchers in collaboration with the pharmaceutical major AstraZeneca.
Following the adverse reaction reports from the UK, the recruitment process has been paused in the US, Brazil and South Africa.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated,” AstraZeneca said in a statement.
As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, the standard review process was triggered and the company voluntarily paused vaccination to allow a review of safety data by an independent committee, AstraZeneca said.
Enrolment for the trials is ongoing in India as well. As many as 1,600 participants are expected to be recruited across 17 sites in the country.
The Oxford vaccine is a viral-vector vaccine that utilises an adenovirus isolated from chimpanzees. Experts said adenovirus vaccines have ‘enviable’ safety dataset amassed from immunizing US troops over the past 60 years.